In part, the trial will explore the use of PGDx's liquid biopsy assay to confirm POLE and POLD1 mutations in solid tumors and to investigate whether those tumor types are responsive to immunotherapy.
The study will evaluate the efficacy and safety of nivolumab (anti-PD-1) alone and in combination with ipilimumab (anti-CTLA-4) in patients with POLE and POLD1 mutations and will collect both blood and tumor tissue samples from patients to look at correlation between mutations detected in a tumor tissue sample and those detected from a blood test.
The study will open in centers in the US and Canada soon. Nivolumab and ipilimumab have well characterized safety profiles.
PGDx provides solutions from biomarker discovery to companion diagnostic development through its CAP/CLIA certified laboratory and is developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide.
Personal Genome Diagnostics is developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by researchers from Johns Hopkins University who are pioneers in cancer genome sequencing and liquid biopsy technologies.
GSK releases decade-long data on Shingrix efficacy
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Charles River Laboratories launches AMAP to reduce animal testing reliance
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Cybin secures additional US patent for CYB003 breakthrough therapy programme
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Biophytis reinforces obesity IP with new patent application
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Fusion Antibodies plc secures contract for OptiPhage library development
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients